FDA Approves Rezlidhia for Relapsed/Refractory Acute Myeloid Leukemia

Rezlidhia was approved for patients with acute myeloid leukemia based on study results showing that more than one-third of patients experienced a complete remission after taking the drug.

The Food and Drug Administration (FDA) has approved Rezlidhia (olutasidenib) for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by the Abbott RealTime IDH1 Assay — a test that was approved alongside the drug.

The approval was based off findings from the phase 1/2 trial, Study 2102-HEM-101, which included 147 patients with relapsed or refractory AML that harbored an IDH1 mutation, as determined by the Abbott RealTime IDH1 Assay.

Patients were given Rezlidhia until their disease got worse, they experienced unacceptable side effects or they underwent a hematopoietic stem cell transplant. On average, patients took the drug for 4.7 months, and 11% (16 patients) underwent transplant.

A total of 35% of patients experienced complete remission plus complete remission with partial hematologic recovery, meaning that there were no signs of cancer and patients had certain levels of neutrophils, platelets and did not need transfusions. On average, the time to complete response plus hematologic recovery was 1.9 months and the average duration was 25.9 months.

Additionally, at the start of the trial, 86 patients were dependent on red blood cell or platelet transfusions, but the majority (29 patients) became independent of transfusions at some point during the 56 days after baseline. For the 61 patients who did not need a transfusion at the start of the trial, 39 remained independent of transfusions during this period.

The most common side effects from Rezlidhia that were seen in 20% or more of patients were nausea, fatigue, joint pain, constipation, increase in white blood cells, fever, rash, mouth sores, diarrhea and changes in liver enzymes. The drug also comes with a Boxed Warning regarding the risk of differentiation syndrome — a complication that involves the release of too many inflammatory molecules into the bloodstream and can be fatal.

The FDA recommends that patients take Rezlidhia twice a day on an empty stomach for a minimum of six months for those who do not experience disease progression or unacceptable side effects.


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